Programming systems for deep brain stimulator system

ABSTRACT

The present technology provides a medical stimulation system having a clinical programmer configured to operate on a computational and memory device having a wireless communication device. The technology also provides a neurostimulator configured to wirelessly communicate with the clinical programmer. The neurostimulator also includes a pulse generator operatively coupled with an electrode by a lead. The pulse generator is configured to transmit an electrical signal comprising a repeating succession of non-regular pulse trains. Each pulse train includes a plurality of pulses having non-regular, non-random, differing inter-pulse intervals therebetween. The pulse trains repeat in succession to treat a neurological condition. Further, the pulse trains are initiated by instructions communicated by the clinical programmer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/107,290, entitled “PROGRAMMING SYSTEMS FOR DEEP BRAIN STIMULATORSYSTEM” filed on Jun. 22, 2016, which claims priority to InternationalApplication No. PCT/US2014/072112, entitled “PROGRAMMING SYSTEMS FORDEEP BRAIN STIMULATOR SYSTEM,” filed on Dec. 23, 2014 and U.S.Provisional Application No. 61/920,154 entitled “PROGRAMMING SYSTEMS FORDEEP BRAIN STIMULATOR SYSTEM,” filed on Dec. 23, 2013, each of which ishereby incorporated by reference in its entirety.

FIELD OF USE

The present invention relates generally to a programming system for animplantable deep brain stimulator.

BACKGROUND

Deep Brain Stimulators (DBS) have been found to be successful intreating a variety of neurological conditions, including, withoutlimitation, movement disorders. Generally, such treatment involvesplacement of a deep brain stimulator type lead into a targeted region ofthe brain through a burr hole drilled in the patient's skull, and theapplication of appropriate stimulation through the lead to the targetedregion.

Presently, in DBS, beneficial (symptom-relieving) effects are observedprimarily at high stimulation frequencies above 100 Hz that aredelivered in stimulation patterns or trains in which the intervalbetween electrical pulses (the inter-pulse intervals) is constant overtime. The beneficial effects of DBS on motor symptoms are only observedat high frequencies, while low frequency stimulation may exacerbatesymptoms. See Benabid et al., 1991, and Limousin et al., 1995. ThalamicDBS at less than or equal to 50 Hz increases tremor in patients withessential tremor. See Kuncel et al. 2006. Similarly, 50 Hz DBS producestremor in pain patients receiving simulation of the ventral posteriormedial nucleus of the thalamus (VPM), but the tremor disappears when thefrequency is increased. See Constantoyannis 2004. Likewise, DBS of thesubthalamic nucleus (STN) at 10 Hz worsens akinesia in patients withParkinson's disease (PD), while DBS at 130 Hz leads to significantimprovement in motor function See Timmermann et al. 2004, and Fogelsonet al. 2005. Similarly, stimulation of the globus pallidus (GP) at orabove 130 Hz significantly improves dystonia, whereas stimulation ateither 5 or 50 Hz leads to significant worsening. See Kupsch et al.2003.

Model studies also indicate that the masking of pathological burstactivity occurs only with sufficiently high stimulation frequencies. SeeGrill et al. 2004, FIG. 1. Responsiveness of tremor to changes in DBSamplitude and frequency are strongly correlated with the ability ofapplied stimuli to mask neuronal bursting. See Kuncel et al. 2007, FIG.2.

Although effective, conventional high frequency stimulation generatesstronger side-effects than low frequency stimulation, and thetherapeutic window between the voltage that generates the desiredclinical effect(s) and the voltage that generates undesired side effectsdecreases with increasing frequency. Precise lead placement thereforebecomes important. Further, high stimulation frequencies increase powerconsumption. The need for higher frequencies and increased powerconsumption shortens the useful lifetime and/or increases the physicalsize of battery-powered implantable pulse generators. The need forhigher frequencies and increased power consumption requires a largerbattery size, and frequent charging of the battery, if the battery isrechargeable. As the stimulator portion of the DBS may be implanted intoa patient, access to the leads, stimulator and the entirety of the DBSis often very difficult.

Once implanted into a patient, altering the battery or altering thestimulation of the system may preferably be avoided as surgery may berequired to achieve such. It is desirable to limit the number of timesthat the implanted system is removed from the patient as every instanceof surgery provides inherent risks that should generally be avoided.

However, there may be overriding benefits to alter some of theparameters of the stimulation applied to the patient, which may requirealtering parts of the system. Therefore, there is a need to alter theparameters of the DBS without requiring explanting of the DBS from thepatient or other surgery.

The stimulation applied to the targeted region may be altered to improvethe performance of the treatment. For example, a pattern of stimulationmay be altered so as to improve the efficiency of the battery of theDBS, improve the efficacy of the treatment or both. However, not everypatient reacts the same way to the stimulation. Accordingly, there is aneed to be able to alter and manage the application of the stimulationto a specific patient or to treat a specific neurological condition.Further, there is a need to have a system that is easy to use for aclinician and patient. Further still, there is a need for a system thatis programmable to alter the application of the stimulation.

SUMMARY

The present technology relates to a programming system applicable to aDBS that applies stimulation to treat any applicable neurologicalcondition. The Clinical Programmer (CP) may provide a mechanism forcommunication with an implantable DBS. The CP may allow communicationbetween a computing device and a wireless communications system. The CPmay allow for data such as DBS stimulation settings, usage, error logs,and other information to be transmitted to and from the CP via thewireless communication system.

In one aspect, the present technology provides a medical stimulationsystem having a clinical programmer configured to operate on acomputational and memory device having a wireless communication device.The technology also provides a neurostimulator configured to wirelesslycommunicate with the clinical programmer. The neurostimulator alsoincludes a pulse generator operatively coupled with an electrode by alead. The pulse generator is configured to transmit an electrical signalcomprising a repeating succession of non-regular pulse trains. Eachpulse train includes a plurality of pulses having non-regular,non-random, differing inter-pulse intervals therebetween. The pulsetrains repeat in succession to treat a neurological condition. Further,the pulse trains are initiated by instructions communicated by theclinical programmer.

In one embodiment, the first electrical signal comprises non-regularpulse trains.

In one embodiment, the second electrical signal comprises secondnon-regular pulse trains or in another embodiment both the first andsecond electrical signal comprises non-regular pulse trains.

In one embodiment, the neurological condition is one of Parkinson'sDisease, Essential Tremor, Movement Disorders, Dystonia, Epilepsy, Pain,Obsessive Compulsive Disorder, Depression, and Tourette's Syndrome.

In one embodiment, the computational and memory device is selected froma tablet computer, a laptop, a smartphone, or another electronic device.

In one embodiment, the wireless communication device of thecomputational and memory device is selected from a 403 MHz radiotransceiver, a 2.4 GHz personal area wireless network, and an ultra-lowpower ultra high frequency (UHF) wireless radio.

In one embodiment, the neurostimulator comprises a unique identifyingcharacteristic.

In one embodiment, the clinical programmer wirelessly communicates withthe neurostimulator by its unique identifying characteristic.

In one embodiment, the wireless communication is secured through the useof encryption, message authentication, message security, or acombination thereof.

In one embodiment, the clinical programmer is managed by an interactiveuser interface operated on the computational and memory device.

In one embodiment, the user interface includes an interactive progressline displaying a progression of tasks for the neurostimulator and aninteractive status bar displaying information related to the currenttask, the interactive status bar. The status bar may include an advancebutton, a pulse stimulation button, an amplitude button, an advancedprogramming screen task button, and a save button. Further, the userinterface may also include an advanced programming screen button, astimulation on-off button, and a screen lock button.

In one embodiment, the progress line displays tasks includes: PatientInformation, Electrode Mapping, Optimize Amplitude, Optimize StimulationFactor, Program & Save, or a combination thereof.

In one embodiment, the progress line identifies the tasks as complete orincomplete.

In one embodiment, the progress line allows a user to select at leastone task, in any desired order. In one embodiment, the preferred orderis the order of completing the tasks as they appear on the progress linefrom left to right (or from right to left as the case may be).

In one embodiment, the at least one task may be Optimize StimulationFactor, which allows the user to associate one or more pattern ofstimulation with at least one patient selectable attribute. For example,in one embodiment, this may include reducing the Stimulation Factor toreduce the overall battery consumption of the neurostimulator. Inanother embodiment, this may include increasing the Stimulation Factorto increase the probability of reducing patient symptoms.

In one embodiment, the clinical programmer allows a user to adjust pulseduration values, stimulus amplitude values of the pulses, or acombination thereof.

In one embodiment, the markers may be set to indicate clinicallysignificant pulse duration values, stimulus amplitude values, or acombination thereof. In one embodiment, the markers are set to indicatestimulation factor values or stimulus amplitude values.

In one embodiment, the technology also includes a patient controlleroperatively connected to the clinical programmer via the wirelesscommunication device. The patient controller allows a user to execute aprogram automated by the clinical programmer through a device other thanthe computational and memory device. Further, in some embodiments theremay be only the patient controller and neurostimulator. In oneembodiment, the patient controller is separate from the computationaland memory device.

In one embodiment, the pulse train repeats indefinitely.

In one embodiment, the pulse train repeats until another pulse trainsequence is selected by the clinical programmer and/or the patientcontroller.

In one embodiment, a waveform shape of at least one of the pulses isdifferent from a second pulse waveform shape of another of the pulses ofthe non-regular pulse train.

In one embodiment, an amplitude of at least one of the pulses isdifferent from a second pulse amplitude of another of the pulses of thenon-regular pulse train.

In one embodiment, each pulse of the plurality of pulses comprises awaveform that is either of monophasic, biphasic, or multiphasic.

In one embodiment, at least one of the pulses comprises a monophasicwaveform.

In one embodiment, at least one of the pulses comprises a biphasicwaveform.

In one embodiment, at least one of the pulses comprises a multiphasicwaveform.

In one aspect, the present technology provides a method including thestep of operating a clinical programmer on a computational and memorydevice having a wireless communication device configured to wirelesslycommunicate with a neurostimulator. The method also includes applyingelectrical current to targeted neurological tissue region according toinstructions supplied to the neurostimulator through the use of theclinical programmer. The electrical current includes a non regular pulsetrain comprising a plurality of pulses having non-regular, non random,differing inter-pulse intervals therebetween. The method may alsoinclude repeating the applying step in succession to treat aneurological condition.

In one aspect, the present technology provides a medical stimulationsystem having a clinical programmer configured to operate on acomputational and memory device having a wireless communication device.The technology also includes a neurostimulator configured to wirelesslycommunicate with the clinical programmer. The neurostimulator mayinclude a pulse generator operatively coupled with an electrode by alead. The pulse generator may be configured to transmit an electricalsignal comprising a repeating succession of non-regular pulse trains.Each pulse train may include a plurality of pulses having non-regular,non-random, differing inter-pulse intervals therebetween. The pulsetrains may be programmed into the neurostimulator by instructions anddata communicated by the clinical programmer. The pulse trains maymodify a state of a patient. Still further in some embodiments, thepulse trains may be regular.

BRIEF DESCRIPTION OF THE DRAWINGS

Operation of the invention may be better understood by reference to thefollowing detailed description taken in connection with the followingillustrations, wherein:

FIG. 1 is a perspective view of a user operating a clinical programmerof a DBS system on a patient;

FIG. 2 is a perspective view of a user operating a clinical programmerfor an implanted neurostimulator system on a patient;

FIG. 3 is a perspective view of an embodiment of a clinical programmer;

FIG. 4 is a view of an embodiment of a screen of the clinicalprogrammer;

FIG. 5 is a view of a screen of the clinical programmer programmingamplitude to the neurostimulator of the patient and utilizing a marker;

FIG. 6 is a view of a screen of the clinical programmer programmingTemporally Optimized Patterns of Stimulation (TOPS) density or TOPSfactor (hereinafter “Stimulation” factor) to the neurostimulator of thepatient and utilizing a marker;

FIG. 7 is a view of a screen of the clinical programmer programmingamplitude to the neurostimulator of the patient and utilizing twoexemplary markers;

FIG. 8 is a flow chart identifying an embodiment of sequence for tuninga TOPS DBS process;

FIG. 9 is a view of a screen of a clinical programmer;

FIG. 10 is a view of a screen of the clinical programmer using TOPS toadjust the pattern to substantially maximize efficiency (i.e., minimizebattery power consumption);

FIG. 11 is a view of a screen of the clinical programmer using TOPS toadjust the pattern to increase effectiveness;

FIG. 12 is a view of a screen of the clinical programmer using TOPS toadjust the pattern to increase effectiveness;

FIG. 13 is a view of a screen of the clinical programmer using TOPS toadjust the pattern to increase effectiveness; and

FIG. 14 is a view of a screen of the clinical programmer using TOPS toadjust the pattern to substantially maximize effectiveness (i.e.,maximum reduction of residual symptoms).

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to exemplary embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings. It is to be understood that other embodiments may be utilizedand structural and functional changes may be made without departing fromthe respective scope of the invention. Moreover, features of the variousembodiments may be combined or altered without departing from the scopeof the invention. As such, the following description is presented by wayof illustration only and should not limit in any way the variousalternatives and modifications that may be made to the illustratedembodiments and still be within the spirit and scope of the invention.

As shown in FIGS. 1-3, the present technology generally comprises a deepbrain stimulation (DBS) system 100 for stimulating tissues of thecentral nervous system. The system 100 may include a lead 101 placed ina desired position in contact with central nervous system tissue. In theillustrated embodiment, the lead 101 is implanted in a region of thebrain, such as the thalamus, subthalamus, or globus pallidus for thepurpose of deep brain stimulation. However, it should be understood, thelead 101 could be implanted in, on, or near the spinal cord; or in, on,or near a peripheral nerve (sensory or motor) for the purpose ofselective stimulation to achieve a therapeutic purpose.

The distal end of the lead 101 carries one or more electrodes 103 toapply electrical pulses to the targeted tissue region. The electricalpulses are supplied by a pulse generator 105 coupled to the lead 101.The lead 101, electrodes 103, and pulse generator 105 are collectivelyreferred to as a neurostimulator 104 for the purposes of thisapplication. The neurostimulator 104 may be any appropriate type offully or partially implantable neurostimulator capable of responsivetreatment of neurological disorders through the use of stimuli, e.g., aMedtronic® neurostimulator, including but not limited to,RestoreSensor®, RestoreUltra®, RestoreAdvanced®, or PrimeAdvanced®neurostimulator.

In the illustrated embodiments, the pulse generator 105 of theneurostimulator 104 is implanted in a suitable location remote from thelead 101, e.g., in the shoulder region. It should be appreciated,however, that the pulse generator 105 could be placed in other regionsof the body or externally.

When implanted, the case of the pulse generator 105 can serve as areference or return electrode. Alternatively, the lead 101 can include areference or return electrode (comprising a bi-polar arrangement), or aseparate reference or return electrode can be implanted or attachedelsewhere on the body (comprising a mono-polar arrangement).

The pulse generator 105 may include an on-board battery to providepower. Currently, batteries must be replaced every 1 to 9 years,depending on the stimulation parameters needed to treat a disorder. Whenthe battery life ends, the replacement of batteries requires anotherinvasive surgical procedure to gain access to the implanted pulsegenerator. As will be described, the system 100 makes possible, amongits several benefits, an increase in battery life by improved control ofthe stimulation parameters needed to treat a disorder. The pulsegenerator 105 may be configured to transmit an electrical signalcomprising a repeating succession of pulse trains. Each pulse train maybe non-regular pulse trains that include a plugrality of pulses havingnon-regular, non-random, differing inter-pulse intervals therebetween.The pulse generator may be configured to transmit first and secondelectrical signals. In one embodiment, the first electrical signalcomprises a first repeating succession of pulse trains. In oneembodiment, the second electrical signal comprising a second repeatingsuccession of pulse trains different from the first repeating successionof pulse trains. Either of the first or second repeating succession ofpulse trains may be initiated by instructions communicated by theclinical programmer. In one embodiment, the first electrical signalcomprises non-regular pulse trains. In another embodiment, the secondelectrical signal comprises second non-regular pulse trains.

The pulse trains may be programmed into the neurostimulator byinstructions and data communicated by the clinical programmer. Stillfurther in some embodiments, the pulse trains may be regular. The pulsetrains, whether regular or non-regular, may modify a state of a patient.

The neurostimulator 104 is capable or receiving and transmittingmessages via a wireless communication system as well as directedprescribed stimulation waveform patterns or trains through the lead 101to the electrode(s) 103, which serve to selectively stimulate thetargeted tissue region. Additionally, the neurostimulator 104 may have aunique identifying characteristic, e.g., a serial number.

The system 100 also includes a clinical programmer (CP) 102. By way of anon-limiting example, the CP 102 may include a computational and memorydevice of any appropriate configuration and type 106 (e.g., a tabletcomputer, a laptop, a smartphone, or another electronic device)comprising a wireless communication device operatively coupled with theimplanted neurostimulator 104. The computational and memory device 106comprises circuitry, a power source, e.g., a battery or a power cord, aswell as a display for reviewing various screens of the CP 102. Thedisplay may be a touch-screen display, or it may be navigable by anattached or detached keyboard, a mouse, a stylus, voice recognitionsoftware, or any other appropriate means. The device 106 may alsoinclude sensors, cameras, microphones, an accelerometer, speakers, ports(e.g., USB port), etc.

FIGS. 1-3 show a user 108 operating the CP 102 on a tablet of anyappropriate type and configuration 106 to apply predeterminedstimulation parameters to a patient 110. The patient 110 may have afully or partially implanted neurostimulator 104 that is wirelesslycoupled with the CP 102 to treat a neurological condition. It should beunderstood, however, that the CP 102 and the neurostimulator 104 may beutilized to treat any appropriate neurological condition, including, butnot limited to, Parkinson's Disease, Essential Tremor, MovementDisorders, Dystonia, Epilepsy, Pain, Obsessive Compulsive Disorder,Depression, and Tourette's Syndrome. It should be understood, therefore,that the teachings set forth herein are not limited to a specificneurological condition. Further, for purposes of this application, theuser 108 may generally be a clinician. However, a user 108 may also beanother caregiver, a family member, a friend, or the patient himself.

The neurostimulator 104 may be operatively connected to the CP 102through the use of a wireless communication system (described below).The CP 102 is a tool that may be used for adjusting, evaluating, andprogramming stimulus patterns and parameters in the neurostimulator 104.The CP 102 may be of any appropriate configuration. By way of anon-limiting example, the CP 102 may include a computational and memorydevice 106 of any appropriate configuration and type (e.g., a tabletcomputer, a laptop, a smartphone, or another electronic device)comprising a wireless communication system operatively coupled with theimplanted neurostimulator 104. As discussed above, the neurostimulator104 may have a unique serial number, so that the CP 102 may providewireless communications directed toward that particular neurostimulator104 through the use of the unique serial number or any other manner ofidentifying itself. For example, the neurostimulator 104 may includedata in a message sent to the CP 102 that identifies itself via a uniqueserial number. Similarly, messages sent from the CP 102 to theneurostimulator 104 may include data in a message header that identifiesthe serial number of the neurostimulator 104 to allow communicationsonly to the desired neurostimulator 104. In one embodiment, one CP 102could have the ability to contact multiple neurostimulators by directingseparate messages to each unique neurostimulator serial number.

The CP 102 may include a user interface 112 that allows the user 108 tomake changes to the stimulus of the neurostimulator 104. The userinterface 112 may be of any appropriate configuration and is not limitedto that shown and described herein. The majority of the user interface112 may present information about and allow for the adjustment ofparameters or features of a screen task or task. The user interface 112may include several screens, each screen including easy to read andunderstand icons that may assist the user 108 with operation of the CP102. The user interface 112 may be pre-programmed or may be programmedby a clinician or service provider such as to be customized. The userinterface 112 may allow the user to obtain information from theneurostimulator 104 through wireless communications. During operation ofthe CP 102, the newly adjusted stimulus settings may be saved to a fileand sent to the neurostimulator 104 or these operations may be performedat a later time in response to a user's action.

FIGS. 4-7 depict an exemplary organization of the user interface 112 ofthe CP 102. It should be understood, however, that this is merely anexemplary embodiment of the screen. The user interface 112 of the CP 102may be of any appropriate configuration and is not limited to that shownand described herein. The user interface 112 may include more or lessinformation than what is shown and described herein. Any appropriateamount and type of information may be included as is necessary. Further,the CP 102 may be programmable to remove or add information required ordesired.

The user interface 112 may be a touch screen, may require use of apointing device or mechanism such as a mouse, may be voice operated, ormay be a combination of any of the above embodiments. A progress line114 near the top of the user interface 112 may depict the progression ofactivities as a patient's neurostimulator 104 is programmed. The usualsequence of tasks on the progress line 114 may be shown going from leftto right across the screen: Patient Information→ElectrodeMapping→Optimize Amplitude→Optimize Stimulation Factor→Program & Save.In one embodiment, this is the preferred sequence of tasks. In otherembodiments, the preferred sequence is completing the tasks in adifferent order than the sequence shown from left to right on thescreen. The patient information may show on the progress line 114, butin some embodiments it may not show. The progress line 114 may appearconsistently across multiple screens of the user interface 112.Alternatively, the progress line 114 may appear in different locationsacross multiple screens of the user interface 112. The progress line 114may be interactive and allow the user 108 to select various tasks in thesequence to bring up a user interface 112 specific to that task, therebyadvancing from one task to the next by clicking on various icons on theprogress line 114. The progress line 114, therefore, allows the user 108to see which tasks have been completed and which remain to be performed.Additionally, the progress line 114 allows the user 108 to complete thetasks in the order provided by the progress line 114 itself from left toright, to complete the tasks out of the usual order from left to righton the progress line 114, or to return and revise and/or repeat a pasttask.

In addition to the progress line 114, the user interface 112 may alsocontain a status bar 116. The status bar 116 may present informationthat is pertinent to the current stimulation program (e.g., theamplitude, the Stimulation Factor, or the frequency in conventional orfixed frequency stimulation, and the estimated battery life or rechargeinterval for a secondary cell neurostimulator). Additionally the statusbar 116 may also indicate the goal of the parameters being applied tothe patient, i.e., more efficiency (longer battery life) or moreefficacy (better reduction in symptoms of the patient). The informationmay be presented in the same location along the status bar 116 at alltimes.

The two right-most buttons of the status bar 116 are buttons that mayinvoke actions. Specifically, the right-most button may be an advancebutton 118 that, when selected, advances the programming sequence to anew task. The button immediately to the left of the advance button 118may be the save button 120. The save button 120 may allow, whenselected, the programmed stimulus patterns and stimulus parameters to besaved; i.e., causes the patient's file inside of the CP 102 to updateand allows those parameters to become the operational stimulus patternsand parameters of the neurostimulator 104.

If a programming session is terminated without selecting the save button120, the user 108 may be warned that the stimulus parameters andpatterns shown have not been saved. The user 108 may then be asked if hewould like to save the stimulus parameters and patterns. Similarly, ifthe stimulus settings were saved, but then changed before the end of thesession, the user 108 may be advised and asked if they want to save therevised settings.

In addition to presenting information about the current stimulationprogrammed, the other buttons of the status bar 116 may also be used tomove between different tasks. For example, selecting an amplitude button122 on the status bar 116 will cause an adjust amplitude screen task tobe displayed. The user 108 may also navigate the CP 102 using theprogress line 114 to move between various tasks. Additionally, thestatus bar 116 may include a Stimulation button 123. Selecting theStimulation button 123 will cause an adjust Stimulation screen task tobe displayed.

If an adjustment is made on the user interface 112, then that task onthe progress line 114 may remain highlighted to remind the user 108 thatan adjustment has been made on that item. Further, the status bar 116may also remain highlighted for the same purpose.

Beneath the status bar 116 on the far right side of the user interfacescreen 112 is an advanced programming screen task button 124.Alternatively, the advanced programming screen task button 124 may beincluded directly in the status bar 116 or elsewhere on the userinterface 112 in a consistent location. When selected, the advancedprogramming screen task button 124 moves the user 108 to an advancedprogramming screen task.

The advanced programming screen may allow the user 108 to review andrevise the secondary stimulus parameters, e.g., the pulse duration ofthe stimulus, the choice of voltage or current control as the amplitudeadjustment, and the frequency of the fixed frequency stimulation. Theadvanced programming screen may also allow the user 108 to setparameters as a default for different patients or patientpopulations/disease states as well as the current patient 110.

The advanced programming screen may also allow the user 108 to reviewthe patient's usage of the neurostimulator 104; i.e., how much timestimulation was turned off, how much time stimulation was turned on, andthe proportion of time spent in the various preprogrammed options.Additionally, the advanced programming screen may also allow the user108 to restore the neurostimulator 104 to the configuration employed inthe past (e.g., stimulus parameters and stimulus patterns) such as afactory or initial setting.

The CP 102 may use files or a database to store the information abouteach patient programmed. The stored information may include the type ofimplanted neurostimulator 104 used, as well as the serial number orother unique identifying number of the neurostimulator 104. The storedinformation may also include a history of stimulus patterns andparameters programmed and the history of patient usage of the DBS system100. The usage history may be automatically retrieved from theneurostimulator every time the patient 110 is linked to the programmerby the user 108. Some of the information may only be stored in the CP102 and/or in files that may be available for sharing with otherclinicians through communications such as e-mail communications,websites, etc. This information may include personal backgroundinformation about the patient 110, such as the patient's diagnosis, thepatient's age, the patient's picture, the patient's age at diagnosis,the date a lead was implanted, etc.

In addition to being saved in the CP 102, this patient-specific data mayalso be stored on a secured web server accessed through the Internet.This may allow the patient's file to be accessed by a user using a CPdifferent from the one originally used with the patient. The Internetcloud based storage may act like a shadow file system; i.e., when theoriginal CP is being used, the cloud based file is updated when the CPsaves a change to the file, but if a CP other than the original CP isbeing used, then the file is retrieved from the cloud at the beginningof the procedure and updated when the new CP file is saved.

The saved information may allow a new user 108 to view a patient'sprogrammed history of stimulus patterns and parameters, as well as theusage history of the neurostimulator 104 by the patient 110. The CP 102may advise the new user 108 if the other stimulus parameters aredifferent than his default values. All the stimulus parameters andstimulus patterns retrieved may be saved in the new patient's fileand/or database records. None of the patient's parameters may be changedwithout a specific action by the user 108 to change them.

When an already programmed patient 110 is linked to the CP 102, thevalues displayed by the CP (in the status bar 116 and on various screentasks) may be the values currently in the neurostimulator 104.

Each task on the user interface 112 may have the majority of the screendisplaying the features or parameters of that task and may includecontrols to allow their adjustment. For example, the controls shown inFIG. 4 are slide controls 126. Rotary controls or horizontal or verticalslide controls may be utilized to adjust a screen task setting—anyappropriate configuration of controls may be used without departing fromthe present teachings. Any control representation may be used providedit displays the present value or setting and displays it in context tothe range (i.e., minimum and maximum values) available.

The slide control 126 shown in FIGS. 4 and 5 may be utilized to adjustthe stimulus amplitude. The value of parameter set by the slide controlmay be adjusted by moving the value along the slide control to anothervalue. This may be accomplished by dragging the slide control, or bytouching or selecting a different value on the scale. Alternatively, avalue may also be entered through typing on a keyboard, or by any otherappropriate manner.

The stimulus parameters and patterns may be adjusted while the stimulusis being provided to the patient 110 in real time. Alternatively, theuser 108 may elect to turn off the stimulation, make a change and thenturn the stimulation back on. Every user interface 112 of the CP 102that allows the user 108 to make changes to the stimulus pattern orstimulus parameters will also have the ability to start stimulation andstop stimulation through the use of a stimulation on-off button 128. Thestimulation on-off button 128 is shown at the bottom right of corner ofthe user interface 112 of FIG. 4, but may be positioned on anyappropriate location and is not limited to the configuration shown. Forexample, the stimulation on-off button 128 may be two separate virtualbuttons, or it may be a virtual toggle switch. The stimulation on-offbutton 128 may always be located in the same position on the userinterface 112 for consistency in user control. Alternatively, thestimulation on-off button 128 may be located in different locations oneach user interface 112. Every user interface 112 may also have a screenlock 129 to prevent the tasks on the user interface from being adjustedif the CP 102 is switched to the “lock” position. The screen lock 129may be two separate virtual buttons, or it may be a virtual toggleswitch. The screen lock 129 may always be located in the same positionon the user interface 112 for consistency in user control.Alternatively, the screen lock 129 may be located in different locationson each user interface 112.

In addition to allowing the slide control to adjust and set the value ofthe parameter being changed, the CP 102 may also allow for the settingof markers 130, such as shown in FIG. 5. A marker 130 may be a visualindication of a setting (e.g., sets of stimulusparameters/characteristics) that was significant to the user 108 duringthe programming process. For example, the markers 130 may be used toidentify the lowest setting at which rapid improvement in symptom reliefwas no longer achieved by higher values, or the setting at which sideeffects became problematic, or any other appropriate characteristicidentifier. In one embodiment, the markers may be set to indicatestimulation factors, stimulation frequencies, pulse duration values,stimulus amplitude values, or a combination thereof. In anotherembodiment, the markers may be set to indicate stimulation factor valuesor stimulus amplitude values.

In one embodiment, markers 130 may be places on a user interface 112 toshow a range of a single parameter. That is, the placement of markers130 on a user interface 112 may allow the clinician to make subsequentchoices about how to program the neurostimulator 104 and/or allow apatient 110 to be able to select their own treatment without the givenrange identified by the markers. For example, FIG. 6 shows theadjustment of the Stimulation Factor with a current setting 132 of 5.0and a previously set marker 134 at 2.5.

The typical uses of a marker 130 during the amplitude adjustmentprocess, per FIG. 7, may include: a marker 130 a assigned to the valueat which the user 108 observes that further increases in amplitude yieldrelatively little further reduction of the symptoms; and another marker130 b assigned at the value at which the user 108 observes anunacceptable level of side effects. The markers 130 may be used to helpthe user 108 make informed choice about the appropriate value in anadjustment process.

The CP 102 may allow the patient 110 to select a different set ofstimulus parameters of the implanted neurostimulator 104 to be adjustedto meet the patient's needs, such as for increased efficacy or increasedefficiency. The CP 102 may be user friendly and easy for a user tooperate. The CP 102 may implement TOPS and be used to adjust the patternof stimulation to meet or otherwise address the patient's needs.

The CP 102 may also be used to adjust and program stimulation with afixed frequency. Importantly, for both stimulation with the TOPS patternand stimulation with a fixed frequency, the screen of the CP 102indicated an Estimated Battery Life 136 (for a primary cell implant) oran Estimated Recharge Interval (for a secondary cell implant) for thestimulus parameters currently set and displayed. This allows the user108 to include an understanding of the likely operating life of theimplant when programming the patient's neurostimulator.

During operation of the CP 102, the newly adjusted stimulus settings maybe saved to a file and sent to the neurostimulator 104 or these tasksmay be performed at a later time in response to a user's action. Theuser interface 112 may allow the user 108 to obtain information from theneurostimulator 104, including, by way of a non-limiting example, thestatus of the battery inside the neurostimulator 104, the stimulusparameters or patterns currently programmed into the stimulator, and/orthe usage history of a patient 110.

As discussed above, the CP 102 may include a computational and memorydevice of any appropriate configuration and type (e.g., a tabletcomputer, a laptop, a smart phone, or another electronic device) with awireless communications link between the neurostimulator 104 and the CP102. The wireless communications link may be an approximately 403 MHzradio transceiver, but is not limited to such. Any appropriate wirelesscommunications link may be utilized, such as by way of a non-limitingexample, a 2.4 GHz personal area wireless network such Bluetooth® LowEnergy or ANT (Dynastream Innovations Inc.: Garmin®). Alternatively, orin addition, the wireless communications link may use any ultra-lowpower ultra high frequency (UHF) wireless radio (i.e., transverseelectromagnetic radiation). The wireless communications link may bephysically and electronically intrinsic to the CP circuitry or may beattached as a peripheral to the CP 102 (e.g., via USB). Similarly, aninductively coupled telemetry system may be used wherein a wand isplaced above the skin over the neurostimulator.

Communication messages including, without limitation, actual data, suchas stimulation settings, usage (compliance) and error logs, and otherdata may be transmitted to and from the CP 102 using a radio link, orany other appropriate method. Characters to detect or correcttransmission errors, and characters to allow secure communications(e.g., authentication and authorization) may also be transmitted usingthe wireless communications link. By way of a non-limiting example, thetransmission may be encrypted to protect against third party use.Additionally, other means of data privacy, security, and authenticationmay be used.

The CP 102 may configure the neurostimulator 104 for the desiredstimulation (e.g., the voltage amplitude; the current amplitude; thedistribution of current across, between, or among electrode surfacesincluding the case of the neurostimulator 104; the pulse duration; thefrequency of a regular stimulus train; or the pulse-to-pulse intervalsof a non-regular pattern of stimulation). Particularly, the CP 102 mayconfigure the neurostimulator 104 to apply a non-regular electricalstimulation pattern as disclosed in U.S. Pat. No. 8,447,405. In oneembodiment, the CP 102 can generate and send a number of patterns to beused by the neurostimulator 104 to generate the pulse timing, e.g.,where each pattern is a sequence of pulse-to-pulse intervals and thesequence may repeat for a predetermined number of times before anotherpattern is selected. Alternatively, the CP 102 can generate and send anumber of patterns to be used by the neurostimulator 104 to generate thepulse timing, e.g., where each pattern is a sequence of pulse-to-pulseintervals and the sequence may repeat indefinitely.

The CP 102 and the neurostimulator 104 may program and retain more thanone stimulus pattern or set of parameters to allow the patient 110 toselect different stimulus options based on their needs or the specificsof their symptoms at the time of use. The user 102 (including thepatient 110) may make this selection using a patient controller (notshown) that may incorporate hardware for the wireless communicationslink. The patient controller may be operatively connected to theneurostimulator via the wireless communication device. The patientcontroller may allow a user to execute a program without use of the CP102. In some embodiment, the program may be automated by the CP 102. Thepatient controller may employ, for example, an external device such as asmall key fob like device or the patient controller may be a personalcomputer, laptop, tablet, smartphone, or the like, and is separate fromthe computational and memory device. Alternatively, the patientcontroller may be the CP 102. In some embodiments, there may be only thepatient controller and neurostimulator in the system. The wirelesscommunications link hardware may be inside the patient controller, orthe hardware may be a separate unit that may operatively attach to theexternal device through a serial port connection. Alternatively, thehardware may be a separate unit with its own internal battery power thatcommunicates with the patient controller through a standard unlicensedwireless communications link (e.g., Bluetooth® or Bluetooth® LowEnergy), or by any other appropriate system. The hardware may thentranslate and re-transmit the messages on the wireless communicationslink used by the neurostimulator 104.

The wireless communications link between the neurostimulator 104 and theexternal patient controller may allow for a separation between thepatient 110 and the patient controller. The patient controller may beheld by a user 108 sitting across or near the patient 110 without thenecessity of direct contact with the patient 110. The user 108 mayprogram the neurostimulator 104 or a patient 110 may change the stimulusoptions himself. Additionally, the wireless communications link may alsobe used to communicate the status of a primary or secondary cell insidethe neurostimulator 104 to the patient 110, user 108, or both. Further,the wireless communications link may also be used to communicate theusage history of the patient 110 (e.g., the quantity of options andduration of usage of each which were selected by the patient 110), orused to refine the strength of the high frequency (HF) magnetic fieldused to charge a secondary cell neurostimulator 104.

To minimize power consumption by the UHF receiver inside theneurostimulator, the neurostimulator 104 may only periodically searchfor incoming wireless communications. A potential downfall of this slowsampling rate may be the latency (or delay) between the message beingready to send and the message actually being sent and received by theneurostimulator. This sampling rate may be increased for several minutes(e.g., 1 to 30 minutes) after a qualified message has been received.This may allow subsequent messages during that interval (e.g., 1 to 30minutes) to have a smaller latency. Alternatively, the neurostimulator104 may also use the presence of a high frequency (HF) magnetic field ora static magnetic field (e.g., from a small permanent magnet) to startthe interval of faster communications sampling by the neurostimulator.

Additional embodiments of the CP according the present teachings aredescribed below. In the descriptions, all of the details and componentsmay not be fully described or shown. Rather, the features or componentsare described and, in some instances, differences with theabove-described embodiments may be pointed out. Moreover, it should beappreciated that these other embodiments may include elements orcomponents utilized in the above-described embodiments although notshown or described. Thus, the descriptions of these other embodimentsare merely exemplary and not all-inclusive nor exclusive. Moreover, itshould be appreciated that the features, components, elements andfunctionalities of the various embodiments may be combined or altered toachieve a desired CP without departing from the spirit and scope of thepresent invention.

The sequence shown in FIG. 8 identifies an exemplary sequence forprogramming stimulation of the DBS system 100 with TOPS, examples ofwhich are disclosed in U.S. Pat. No. 8,447,405, which is herebyincorporated by reference in its entirety.

The stimulation provided by the TOPS technology differs fromconventional stimulation technology. The stimulation waveform pattern ortrain generated by the pulse generator 105 from input provided to the CP1 differs from convention pulse patterns or trains in that the waveformcomprises repeating non-regular (i.e., not constant) pulse patterns ortrains, in which the interval between electrical pulses (the inter-pulseintervals or IPI) changes or varies over time. Compared to conventionalpulse trains having regular (i.e., constant) inter-pulse intervals, thenon-regular (i.e., not constant) pulse patterns or trains provide alower average frequency for a given pulse pattern or train, where theaverage frequency for a given pulse train (expressed in hertz or Hz) isdefined as the sum of the inter-pulse intervals for the pulse train inseconds (ΣIPI) divided by the number of pulses (n) in the given pulsetrain, or (ΣIPI)/n. A lower average frequency makes possible a reductionin the intensity of side effects, as well as an increase in the dynamicrange between the onset of the desired clinical effect(s) and sideeffects, thereby increasing the clinical efficacy and reducingsensitivity to the position of the electrode(s). A lower averagefrequency brought about by a non-regular pulse pattern or train alsoleads to a decrease in power consumption, thereby prolonging batterylife and reducing battery size.

The repeating non-regular (i.e., not constant) pulse patterns or trainscan take a variety of different forms. For example, as will be describedin greater detail later, the inter-pulse intervals can be linearlycyclically ramped over time in non-regular temporal patterns (growinglarger and/or smaller or a combination of each over time); or beperiodically embedded in non-regular temporal patterns comprisingclusters or groups of multiple pulses (called n-lets), wherein n is twoor more. For example, when n=2, the n-let can be called a doublet; whenn=3, the n-let can be called a triplet; when n=4, the n-let can becalled a quadlet; and so on. The repeating non-regular pulse patterns ortrains can comprise combinations of single pulses (called singlets)spaced apart by varying non-regular inter-pulse intervals and n-letsinterspersed among the singlets, the n-lets themselves being spacedapart by varying non-regular inter-pulse intervals both between adjacentn-lets and between the n pulses embedded in the n-let. If desired, thenon-regularity of the pulse pattern or train can be accompanied byconcomitant changes in waveform and/or amplitude, and/or duration ineach pulse pattern or train or in successive pulse patterns or trains.

Each pulse comprising a singlet or imbedded in an n-let in a given traincomprises a waveform that can be monophasic, biphasic, or multiphasic.Each waveform possesses a given amplitude (expressed, e.g., in amperes)that can, by way of example, range from 10 μa (E-6) to 10 ma (E-3). Theamplitude of a given phase in a waveform can be the same or differ amongthe phases. Each waveform also possesses a duration (expressed, e.g., inseconds) that can, by way of example, range from 10 μs (E-6) to 2 ms(E-3). The duration of the phases in a given waveform can likewise bethe same or different. It is emphasized that all numerical valuesexpressed herein are given by way of example only. They can be varied,increased or decreased, according to the clinical objectives.

When applied in deep brain stimulation, it is believed that repeatingstimulation patterns or trains applied with non-regular inter-pulseintervals can regularize the output of disordered neuronal firing, tothereby prevent the generation and propagation of bursting activity witha lower average stimulation frequency than required with conventionalconstant frequency trains, i.e., with a lower average frequency thanabout 100 Hz. This sequence may optimize the stimulus settings with theminimum of iterative re-adjustments.

The sequence shown in FIG. 8 identifies an exemplary sequence forprogramming stimulation of a DBS system with pulse stimulation—but thepresent teachings are not limited to this sequence. The sequence may bealtered, i.e., steps may be done in a different order, steps may beskipped or steps may be added without departing from the presentteachings. The sequence may begin by optimizing electrode surfacemapping and current distribution through fixed frequency stimulation orpulse stimulation at a dynamically adjusted stimulus amplitude highenough to achieve symptom reduction and below the level creating sideeffects 138. The fixed frequency stimulation may be at a frequency theuser 108 prefers; or it may be at a typical or usual value for thedisease state or neurological condition being treated. Similarly, allstimulation may be at a pulse duration the user 108 prefers; or it maybe at a typical or usual value for the disease state or neurologicalcondition being treated. Subsequent adjustments of the pulse durationare only made in unusual conditions where the usual process isunsuccessful.

The sequence may continue by optimizing stimulus amplitude using fixedfrequency stimulation or stimulation with a pulse stimulation patternwith the optimal electrode surface mapping 140. This may be accomplishedby setting an initial goal, choosing an amplitude mid-way between thelowest amplitude at which increases in amplitude no longer produces acorresponding reduction of symptoms and the highest amplitude that doesnot have undesirable side effects. The amplitude should be kept fixed atthis value and the user 108 may begin adjusting the TOPS factor(hereinafter “Stimulation factor”), i.e., the pulse stimulation pattern.The goal is to choose a Stimulation factor such that further increasesin the Stimulation factor do not produce a significant reduction of thepatient's symptoms 142. The Stimulation factor is a parameter that asits value increases from a minimum to a maximum, the temporal pattern ofstimulation may vary in many ways; however, the average number of pulsesper second may also increase from a minimum to a maximum.

The user 108 will then determine if this sequence is providing adequatetreatment. If yes, the user 108 is done. If not, the user 108 shouldkeep the TOPS factor fixed at the value just set, and readjust theamplitude 144. The goal is to choose an amplitude mid-way between thelowest amplitude at which increases in amplitude no longer produces acorresponding reduction of symptoms and highest amplitude that does nothave undesirable side effects.

The user 108 may again determine if this sequence is providing adequatetreatment. If yes, then the user 108 is done. If not, the user 108 mayreturn to an earlier step in the sequence 142 or 144, e.g., adjustingthe Stimulation factor, but typically more than one pass through thispathway may not be necessary to improve the quality of the treatment forthe patient 110.

FIGS. 9-14 depicts an exemplary organization of a user interface 112 ofthe CP 102. It should be understood, however, that this is merely anexemplary embodiment of the screen.

FIG. 9 exemplifies a generic user interface 112. FIG. 10 exemplifies asetting to apply a pulse stimulation pattern for improved efficiency.FIG. 11 exemplifies a setting to apply a pulse stimulation pattern toimprove effectiveness from FIG. 10. FIG. 12 exemplifies a setting toapply to pulse stimulation pattern to balance efficiency andeffectiveness. FIG. 13 exemplifies a setting to apply a pulsestimulation pattern to improve effectiveness from FIG. 12. FIG. 14exemplifies a setting to apply a pulse stimulation pattern to improveeffectiveness from FIG. 13. It should be understood, however, that thesescreen representations are merely exemplary and not intended to belimiting. Any appropriate configuration may be used without departingfrom the present teachings. For example, the CP 102 allows the user 108to associate one or more TOPS patterns and/or conventional stimulusparameters, with at least one patient selectable attribute/descriptor,e.g., low energy mode for sleep, highest efficacy (reduction ofsymptoms) for special patient events, etc. For example, in oneembodiment, this may include reducing the Stimulation Factor to reducethe overall battery consumption of the neurostimulator. In anotherembodiment, this may include increasing the Stimulation Factor toincrease the probability of reducing patient symptoms—or may include acombination of any of the foregoing. In one embodiment, the CP 102 maymake use of a single control to adjust multiple, interrelated stimulusparameters and pulse timing patterns in a coordinated fashion to movealong a desirable pathway of clinical effects. In another embodiment, asingle control may select one of many pulse stimulation patterns as thecontrol is adjusted from lowest power consumption (longestneurostimulator operating/service life) to the greatest powerconsumption (and shortest neurostimulator operating/service life). Inyet another embodiment, a single control adjusts per pulse stimulusintensity by adjusting both stimulus amplitude and pulse duration incoordinated and clinically/physiologically desirable fashion.

Although the embodiments of the present invention have been illustratedin the accompanying drawings and described in the foregoing detaileddescription, it is to be understood that the present invention is not tobe limited to just the embodiments disclosed, but that the inventiondescribed herein is capable of numerous rearrangements, modificationsand substitutions without departing from the scope of the claimshereafter. The claims as follows are intended to include allmodifications and alterations insofar as they come within the scope ofthe claims or the equivalent thereof.

Having thus described the invention, we claim:
 1. A medical stimulationsystem comprising: a clinical programmer operational on a computationaland memory device having a wireless communication device; and aneurostimulator configured to wirelessly communicate with the clinicalprogrammer, the neurostimulator including a pulse generator operativelycoupled with an electrode by a lead; the pulse generator configured totransmit first and second electrical signals, the first electricalsignal comprising a first repeating succession of pulse trains, thesecond electrical signal comprising a second repeating succession ofpulse trains different from the first repeating succession of pulsetrains, wherein either of the first or second repeating succession ofpulse trains are initiated by instructions communicated by the clinicalprogrammer.
 2. The medical stimulation system of claim 1, wherein thefirst electrical signal comprises non-regular pulse trains.
 3. Themedical stimulation system of claim 1, wherein the second electricalsignal comprises second non-regular pulse trains.
 4. The medicalstimulation system of claim 1, wherein the first repeating succession ofnon-regular pulse trains includes a plurality of pulses havingnon-regular, non-random, differing inter-pulse intervals therebetween.5. The medical stimulation system of claim 1, wherein the secondrepeating succession of non-regular pulse trains includes a plurality ofpulses having non-regular, non-random, differing inter-pulse intervalstherebetween.
 6. The medical stimulation system of claim 1, wherein theneurological condition is one of Parkinson's Disease, Essential Tremor,Movement Disorders, Dystonia, Epilepsy, Pain, Obsessive CompulsiveDisorder, Depression, and Tourette's Syndrome.
 7. The medicalstimulation system of claim 1, wherein the computational and memorydevice is selected from a tablet computer, a laptop, a smartphone, oranother electronic device.
 8. The medical stimulation system of claim 1,wherein the wireless communication device of the computational andmemory device is selected from a 403 MHz radio transceiver, a 2.4 GHzpersonal area wireless network, and an ultra-low power ultra highfrequency (UHF) wireless radio.
 9. The medical stimulation system ofclaim 1, wherein the neurostimulator comprises a unique identifyingcharacteristic.
 10. The medical stimulation system of claim 1, whereinthe clinical programmer wirelessly communicates with the neurostimulatorby its unique identifying characteristic.
 11. The medical stimulationsystem of claim 1, wherein the wireless communication is secured throughthe use of encryption, message authentication, message security, or acombination thereof.
 12. The medical stimulation system of claim 1,wherein the clinical programmer is managed by an interactive userinterface operated on the computational and memory device.
 13. Themedical stimulation system of claim 12, wherein the user interfacecomprises: an interactive progress line displaying a progression oftasks for the neurostimulator; an interactive status bar displayinginformation related to the current task, the interactive status barcomprising: optionally an advance button; optionally a pulse stimulationbutton; optionally an amplitude button; optionally an advancedprogramming screen task button; and optionally a save button; anadvanced programming screen button; a stimulation on-off button; and ascreen lock button.
 14. The medical stimulation system of claim 13,wherein the progress line displays tasks including: Patient Information,Electrode Mapping, Optimize Amplitude, Optimize Stimulation Factor,Program & Save, or a combination thereof.
 15. The medical stimulationsystem of claim 14, wherein the progress line identifies the tasks ascomplete or incomplete.
 16. The medical stimulation system of claim 15,wherein the progress line allows a user to select at least one task, inany desired order.
 17. The medical stimulation system of claim 16,wherein the at least one task may be an optimized stimulation factor,which allows the user to associate one or more pattern of stimulationwith at least one patient selectable attribute.
 18. The medicalstimulation system of claim 12, wherein the clinical programmer allows auser to adjust pulse duration values, stimulus amplitude values of thepulses, or a combination thereof.
 19. The medical stimulation system ofclaim 18, wherein markers are set to indicate stimulation factors,stimulation frequencies, pulse duration values, stimulus amplitudevalues, or a combination thereof.
 20. The medical stimulation system ofclaim 19, wherein the markers are set to indicate stimulation factor orstimulus amplitude values.
 21. The medical stimulation system of claim1, further comprising a patient controller operatively connected to theneurostimulator via the wireless communication device, the patientcontroller allows a user to execute a program without use of theclinical programmer.
 22. The medical stimulation system of claim 21,wherein the program is automated by the clinical programmer.
 23. Themedical stimulation system of claim 22, wherein the patient controlleris separate from the computational and memory device.
 24. The medicalstimulation system of claim 1, wherein the pulse train repeatsindefinitely.
 25. The medical stimulation system of claim 1, wherein thepulse train repeats until another pulse train sequence is selected onthe clinical programmer or patient controller.
 26. The medicalstimulation system of claim 1, wherein a waveform shape of at least oneof the pulses is different from a second pulse waveform shape of anotherof the pulses of the non-regular pulse train.
 27. The medicalstimulation system of claim 1, wherein an amplitude of at least one ofthe pulses is different from a second pulse amplitude of another of thepulses of the non-regular pulse train.
 28. The medical stimulationsystem of claim 1, wherein each pulse of the plurality of pulsescomprises a waveform that is either of monophasic, biphasic, ormultiphasic.
 29. The medical stimulation system of claim 1, wherein atleast one of the pulses comprises a monophasic waveform.
 30. The medicalstimulation system of claim 1, wherein at least one of the pulsescomprises a biphasic waveform.
 31. The medical stimulation system ofclaim 1, wherein at least one of the pulses comprises a multiphasicwaveform.